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The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Other | Remote-Only subjects |
|
| Cohort B | Other | Remote + Imaging subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Program 1 | Device | 2/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Composite from Creyos (formerly Cambridge Brain Sciences) | The Overall Composite is derived from the 12 tests in the Creyos battery. | Study Day 0 to Study Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration Domain Score from Creyos | Study Day 0 to Study Day 84 | |
| Memory Domain Score from Creyos | Study Day 0 to Study Day 84 | |
| Planning Domain Score from Creyos |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Cohort B only:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Madore, PhD | Lumos Labs, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lumos Labs, Inc. | San Francisco | California | 94108 | United States |
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| Digital Program 2 | Device | 1/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation |
|
| Study Day 0 to Study Day 84 |
| Reasoning Domain Score from Creyos | Study Day 0 to Study Day 84 |
| Structural Brain Composite from Magnetic Resonance Imaging (MRI) | Study Day 0 to Study Day 84 |
| White Matter Microstructure Composite from Diffusion Magnetic Resonance Imaging (dMRI) | Study Day 0 to Study Day 84 |
| Within-Network Functional Connectivity from Resting-State functional Magnetic Resonance Imaging (fMRI) | Study Day 0 to Study Day 84 |